FDA Label for Glowell Spf 30 Tinted Mineral Sunscreen Medium

View Indications, Usage & Precautions

Glowell Spf 30 Tinted Mineral Sunscreen Medium Product Label

The following document was submitted to the FDA by the labeler of this product Glowell, Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

Distributed by: Glowell, LLC.
South Plainfield, NJ 07080.


Otc - Purpose



Active ingredientsPurpose
Zinc Oxide 14.20%Sunscreen
Titanium Dioxide 0.5%Sunscreen

Uses



  • Helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings



  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop and ask a doctor if a rash occurs.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

Directions



  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 80 minutes of swimming or sweating.
    • Immediately after towel drying.
    • at least every two hours.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 am – 2pm.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.
      • Children under 6 months: Ask a doctor.

Inactive Ingredients



  • Deionized Water, Isododecane, C12-15 Alkyl Benzoate, Iron Oxide, Butylene Glycol, Polyglyceryl-3 Diisostearate, Mica, Cocos Nucifera (Coconut) Oil, Quaternium-90 Bentonite, VP/Eicosene Copolymer, Butyrospermum Parkii (Shea) Butter, Polyhydroxystearic Acid, Gluconolactone (and) Sodium Benzoate, Fragrance, Propylene Carbonate, Bismuth Oxychloride, Triethoxycaprylylsilane, Tocopherol, Titanium Dioxide (CI77891), Ethyl Ferulate.

Other Information



  • Protect this product from excessive heat and direct sun. Wash with soap to remove from skin.

Questions Or Comments?



Call 1-833-GLOW-SPF


Principal Display Panel - 147 Ml Tube Label - Light



GLO
WELL®

SPF30

TINTED
MINERAL
SUNSCREEN

ADAPTS TO SKIN TONE
WITH A BUILDABLE
GLOWING FINISH

FOR
LIGHT SKIN
TONES

UVA/UVB BROAD SPECTRUM SPF 30
WATER RESISTANT 80 MINUTES
5FL OZ. (147mL)


Principal Display Panel - 147 Ml Tube Label - Medium



GLO
WELL®

SPF30

TINTED
MINERAL
SUNSCREEN

ADAPTS TO SKIN TONE
WITH A BUILDABLE
GLOWING FINISH

FOR
MEDIUM SKIN
TONES

UVA/UVB BROAD SPECTRUM SPF 30
WATER RESISTANT 80 MINUTES
5FL OZ. (147mL)


Principal Display Panel - 147 Ml Tube Label - Tan



GLO
WELL®

SPF30

TINTED
MINERAL
SUNSCREEN

ADAPTS TO SKIN TONE
WITH A BUILDABLE
GLOWING FINISH

FOR
TAN SKIN
TONES

UVA/UVB BROAD SPECTRUM SPF 30
WATER RESISTANT 80 MINUTES
5FL OZ. (147mL)


Principal Display Panel - 147 Ml Tube Label - Deep



GLO
WELL®

SPF30

TINTED
MINERAL
SUNSCREEN

ADAPTS TO SKIN TONE
WITH A BUILDABLE
GLOWING FINISH

FOR
DEEP SKIN
TONES

UVA/UVB BROAD SPECTRUM SPF 30
WATER RESISTANT 80 MINUTES
5FL OZ. (147mL)


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